**Description:**
*Primary Function/ Primary Goals/ Objectives** 主な役割**/**目標**/**目的***
Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
The Associate Clinical Operations Manager (ACOM) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites. May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues).
Additionally, the ACOM may train and provide guidance to junior staff.
**Qualifications:**
*Core Job Responsibilities/** **Accountability / Scope ( Major Duties and Responsibilities)** ***
*ｱｶｳﾝﾀﾋﾞﾘﾃｨ**(**主な責任**)/**範囲***
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Supports the Clinical Operations Manager (COM) and/or Senior Clinical Operations Manager (SrCOM) in the provision of leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US) / region (US) of responsibility.
In the country/region based, may manage up toapp. 126SiteCRAs responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies.
Gives support in providing ongoing assessment of resource needs and in allocating resources in alignment with AbbVie’s research goals, priorities and specific study timelines. Identifies and communicates issues that impact resource allocation and provides solutions.
For direct reports, ensures clinical monitoring activities are conducted according to the monitoring plan and are in accordance with project timelines and company objectives. Anticipates and identifies site issues that could affect timelines and develops alternative solutions.
Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues, than those assigned to (Sr) SCRAs.
Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
Is proactive in managing the site and ensures action plans are put in place as needed to ensure compliance.
Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
Appropriately reports and escalates serious or outstanding issues to project team member(s) and/or Senior ACOM/ COM/ Sr COM as appropriate, as defined in the study monitoring plan.
Facilitates Quality Assurance Audit processes as indicated.
Ensures regulatory inspection readiness at assigned clinical sites.
Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline by enhancing the enrollment schedule of clinical investigative sites.
Reviews monitoring visit reports for assigned CRA’s. May act as back-up or secondary reviewer for other countries as required.
Reports monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
Participates in field training and mentoring of new/junior SCRAs as well as insourced SCRAs. May provide input relative to performance review and development opportunities.
Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues.
Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met.
Prepares CA (Country Agency) and/or EC (Ethical Committee = IRB) documentation, ensures submissions and/or notifications are performed as applicable. Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up.
May coordinate local SCRA team working on the same projects, when applicable.
Supports remote monitoring, if and as applicable.
Employs excellent financial management to conserve costs of departmental operation and controls travel expenses, with guidance from Senior ACOM/ COM/ Sr COM as appropriate.
Provides hands-on assistance to assigned staff for project implementation as needed. Where appropriate, monitors project progress against time frame and budget. Informs the Clinical Operations Manager and/or the Senior Clinical Operations Manager of any variance.
Supports the Clinical Operations Manager and/or Senior Clinical Operations Manager in ensuring that globally accepted compliance standards are met in the country based, and that quality standards in the conduct of clinical research are maintained.
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and to quality standards in conducting clinical research.
Manages investigator payments as per executed contract obligations.
Negotiates investigator/ hospital agreements with stakeholders
Maintain and complete own expense reports as per local and applicable guidelines.
Identifies, evaluates and recommends new/potential investigators/sites on an on-going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
Participates in and/or presents at departmental and other functional meetings as needed, including Site Management & Monitoring meetings.
Participates in special projects/work groups.
Identifies and partners with other AbbVie personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations while conserving overall departmental operating costs.
Maintains knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness and trends of industry practices and participation in professional activities.
Creates a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.
Maintains appropriate communication with relevant functional areas.
Undergoes and maintains training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
Typically based in a large business unit to support the Clinical Operations Manager.
Typically responsible for a number (1–6) of monitoring staff within one country/region while keeping some site management (CRA-) responsibilities.
Uses multiple technologies to maintain open and frequent communication with internal & external customers.
Interacts with, builds and maintains professional and collaborative relationships with:
- Study personnel (investigators, study coordinators, pharmacists, etc)
- Peers within the organization
- Study Teams/ Document Management
May interface with:
- Local personnel including Medical Department personnel and other AbbVie personnel within Clinical Operations as well as Safety Representatives, Regulatory, Finance and Legal Functions, Human Resources, administrative staff and other relevant functional areas.
External service providers
* *
*Education** 教育***
Bachelor’s Degree required; medical/science/nursing background preferred;
MS, MA, MBA, MPH desired
*Background (Experience)** 経歴 **(**経験**)*
Minimum of 5 years of clinical related experience, with a minimum of 2 years as clinical research monitor.
Expert knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
Expert knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
Experience in on-site monitoring of investigational drug in multi-therapeutic areas desired.
* *
*Required Functional Competencies** その役割に必要とされるｺﾝﾋﾟﾃﾝｼｰ***
Proven strong site management and monitoring skills
Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Excellent written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
Acute observational skills, analytical and conceptual capabilities.
Exhibit high degree of flexibility when facing changes in the work environment
Attention to detail and strong interpersonal skills.
Proficiency in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications.
Working knowledge and high experience with electronic data capture systems and clinical trials management systems.
Strong ability to work independently in a geographic region with minimal supervision.
The ACOM anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The ACOM should use functional expertise and exercise good judgment in seeking appropriate guidance and ensures that follow-up to any and all corrective action is taken at the clinical site and is properly documented.
The ACOM may be assigned as Country Project Lead (functional role – see role description “Country Project Lead”) and serve as a “study Subject Matter Expert (SME)” regarding monitoring/site management tasks in support of Site Management & Monitoring staff assigned to a particular protocols.
Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
**Job Classification:** Experienced
**Job:** RESEARCH AND DEVELOPMENT
**Primary Location:** Japan-Tokyo-To-Tokyo
**Organization:** Research & Development
**Schedule:** Full-time
**Shift:** Day
**Travel:** Yes, 20 % of the Time
**Req ID:** 1701452